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NCT05250973 · ClinicalTrials.gov registry record · Phase 2
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
A Phase 2 study of Amyloidosis, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT05250973: Active Phase 2 study of Amyloidosis, sponsored by Janssen Research & Development.
NCT05250973 is a Phase 2 study of Amyloidosis that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 151 participants, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05250973, a Phase 2 study of Amyloidosis, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).
Primary Outcome
Number of participants with cardiac events of any toxicity grade will be reported.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Bortezomib
Study Locations (20)
Massachusetts
- Tufts Medical Center - Boston
- Boston University Medical Center - Boston
North Carolina
- Levine Cancer Institute - Charlotte
- Wake Forest University - Baptist Medical Center - Winston-Salem
Ohio
- University Hospital of Cleveland - Cleveland
- Ohio Health Research Institute - Columbus
Alberta
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute - Edmonton
California
- City of Hope - Duarte
Connecticut
- Smilow Cancer Hospital/Yale Cancer Center - New Haven
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2027-03-02 |
| Phase | Phase 2 |
What the registry record for NCT05250973 still lists
NCT05250973 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Amyloidosis appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT05250973 names 20 study sites across 16 states, led by Massachusetts, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT05250973 about?
NCT05250973 is a clinical study titled "A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis". The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis...
What is the current status of trial NCT05250973?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2022-03-01. Estimated completion is 2027-03-02.
What conditions does trial NCT05250973 study?
This clinical trial studies the following conditions: Amyloidosis.
What interventions are being tested in trial NCT05250973?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT05250973?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05250973 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05250973's enrollment target sits among peer trials
151 12th of 28 higher than 17 of 28 other Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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